NDC Code(s) : 70645-804-26
Packager : 7T Pharma LLC

Category : MEDICAL DEVICE

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

7T LidoLidocaine Hydrochloride and Benzethonium Chloride GEL
Product Information
Product Type MEDICAL DEVICE Item Code (Source) NDC:70645-804
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE2 mg in 100 mg
BENZETHONIUM CHLORIDE(UNII: PH41D05744)
(BENZETHONIUM - UNII:1VU15B70BP) 		BENZETHONIUM CHLORIDE0.5 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
MARINE COLLAGEN, SOLUBLE(UNII: 8JC99XGU4W)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%)(UNII: L605B5892V)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TROLAMINE(UNII: 9O3K93S3TK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70645-804-2685000 mg in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
PREMARKET NOTIFICATION K020540 08/01/2018

LABELER - 7T Pharma LLC(080220022)

PRINCIPAL DISPLAY PANEL

7T Lido Gel

Rx ONLY

NDC 70645-804-26

3oz (85g)

7T Lido Gel Rx ONLY NDC 70645-804-26 3oz (85g)